ES2667950T3 - Elastomeric thread with anchoring structures for anchoring in biological tissues - Google Patents

Abstract

Elastomeric thread (100), more particularly for use as a wound closure system without knots or self-fixing, where the thread (100) includes on its surface anchoring structures (120) for anchoring in biological tissues, more particularly human and / or animals, characterized in that the anchoring structures (120) in the absence of an axial tensile load in the thread (100) essentially do not protrude from the surface of the thread, so that the thread (100) has a surface essentially smooth and the anchoring structures (120) are configured to be erected by imposing an axial tensile load on the thread (100).

Description

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Elastomeric thread with anchoring structures for anchoring in biological tissues

[0001] The present invention relates to an elastomeric thread, a wound closure system based thereon, a surgical equipment of parts and a process for producing the elastomeric thread. The standard way to close wounds in surgery is to use sutures formed with thread. These are typically knotted to secure secure fixation in the tissue. Here, care must be taken to ensure that the wounds to be closed are sewn using optimal force at the edges of the wound. If, for example, the edges of the wound are sewn too loosely and too unevenly, there is a risk in principle of increased scarring or dehiscence. On the other hand, if the edges of the wound are sewn too tightly, there is a risk that blood flow will be restricted through the edges of the wound, which can lead to necrotic changes in the region around the tissue.

[0002] In addition to the risk of possible secondary complications, which may require renewed surgical interventions, there is also a certain risk that wound closures based on knotted sutures will lead to alterations in the healing process and more particularly to unsatisfactory cosmetic surgeries for the affected patient. Another factor is that several knots are often necessary, more particularly up to seven knots, which must be placed on top of each other to ensure a secure knotted grip. This means that there is a lot of material that is introduced into the region of the wound to be treated and may result in greater reactions to foreign bodies, more particularly in the case of absorbable sutures. In addition, the use of conventional sutures can also be a disadvantage in the management of hard-to-reach indication fields, as typically occurs in laparoscopy.

[0003] Sutures that, as opposed to known or conventional threads, should not be knotted have already been known for some time under the designation of "barbed sutures." Such sutures without knots or self-locking / self-locking / self-locking normally consist of a monofilament thread that has spikes along its longitudinal axis. Corresponding sutures are described, for example, in printed publications US 3,123,077 A, EP 1 559 266 B1, EP 1 560 683 B1 and EP 1 556 946 B1. The barbs are generally formed on the surface of the thread so that the thread can be pulled through the fabric in the direction of the barbs without great resistance and more particularly without significant trauma to the tissue. When pulled in the opposite direction, however, the spikes unfold and anchor themselves and, therefore, also the suture, in a region of surrounding tissue. This prevents the suture from being removed through a puncture channel formed by the suture.

[0004] US 2004/060409 A1 discloses self-retaining elastomeric sutures with tissue retainers, according to the preamble of independent claim 1. It is a great disadvantage that, given that the knotless or self-fixing sutures described in the preceding section are introduced into the tissue, the spikes, which generally protrude from the surface of the thread, may result in additional tissue irritation. In addition, like the generation of tissue trauma, protruding spikes give rise to a greater puncture channel while pulling them through the tissue. To avoid further irritation or generation of tissue trauma, therefore, appropriate auxiliary means are frequently employed. For example, facial surgery techniques are known where a thin tube is initially conducted through the tissue to be treated before a barbed suture with spikes is conducted through this tube. After the correct placement of the suture, the tube is removed, which causes the spikes to be erected and, therefore, to be able to anchor the suture in the region of the surrounding tissue. There are other surgical methods where a barbed suture with barbs is pulled together with a flexible tube surrounding the suture through tissue to be treated. Once the sheathed suture is correctly placed, the flexible tube is removed, making it possible for the suture to be anchored by means of its barbs. Appropriate auxiliary means and suture systems based thereon are described, for example, in printed publications US 6,241,747 B1 and DE 10 2005 004 318 A1. The use of additional auxiliary means makes the methods described above more costly, inconvenient and complicated to carry out and thus increases the likelihood of errors associated therewith.

[0005] It is an object of the present invention to provide a wound closure system without knots or self-fixation, ideally without trauma, which with respect to its construction and more particularly to its manipulation corresponds in principle to a surgical suture, but which does not require auxiliary means. additional to prevent trauma to the tissue by introducing the wound closure system into a biological tissue.

[0006] We have discovered that this object is achieved by an elastomeric thread having the characteristics of independent claim 1. Embodiments of the thread of the present invention are the subject of dependent claims 2 to 12. A further aspect of the present The invention relates to a wound closure system having the characteristics according to independent claim 13. The present invention also further comprises a surgical equipment of parts with the characteristics of independent claim 14. A

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Additional aspect of the present invention relates to a process for the production of the yarn of the present invention according to independent claim 15. The wording of all claims is hereby incorporated herein by reference.

[0007] The yarn of the present invention comprises an elastomeric yarn, preferably for use as a wound closure system without knots or self-fixation, more particularly in the manner of a surgical suture without knots or self-fixation, where the thread includes on its surface anchor structures for anchoring in biological tissues, more particularly human and / or animals. In other words, the invention provides a thread based on an elastomeric material, generally a polymer with elastomeric or elastic properties (a so-called elastomer), where the anchor structures are formed on the surface of the thread for anchoring the thread in biological tissues.

[0008] Biological tissues may in principle comprise hard and / or soft tissues. The tissues are preferably selected from the group consisting of skin, fat, fascia, bone, muscle, organs, nerves, blood vessels, connective tissue, ropes, tendons and ligaments. The yarn of the present invention is generally useful for tissue fixation and / or tissue elevation. The elastomeric yarn is more particularly suitable for applications in plastic surgery, preferably for skin tightening. For example, the elastomeric thread is suitable for raising the eyebrows. Other fields of application are cheek corrections and / or jaw lines. In addition, however, the thread of the present invention is also suitable for other surgical indications, more particularly for indications where the use of conventional sutures is difficult due to steric hindrance, for example. The elastomeric thread is, therefore, particularly useful for performing laparoscopic interventions. An additional field of use concerns the fixation of implants, more particularly textile implants. Examples of textile implants include hernia, prolapse and urinary incontinence meshes. A possible additional field of application for the yarn of the present invention relates to the performance of anastomosis, in particular vascular or intestinal anastomosis.

[0009] In the elastomeric thread of the present invention, the anchoring structures in the absence of an axial tensile load in the thread (relaxed or unstretched state of the thread) essentially do not protrude from the surface of the thread, so that the thread It has an essentially smooth surface. As a result, trauma to the tissue by pulling the thread through a biological tissue can be substantially avoided. The term "essentially smooth" should be understood herein to include minor elevations in the surface of the thread that are capable of resulting from a position of the anchoring structures close to the surface of the thread in the unstretched state of the thread. Ideally, however, the surface of the thread is completely smooth in the relaxed or unstretched state of the thread.

[0010] The anchoring structures themselves can be erected, more particularly they can be erected reversibly. The anchoring structures can be erected by imposing an axial tensile load on the wire, that is by applying a tensile force in the longitudinal direction of the wire, preferably at its ends. When the thread is extended or stretched by applying an axial tensile force, the anchoring structures are erected with particular advantage. The anchor structures are erected due to the applied force that, although extending the thread while simultaneously reducing the diameter of the thread, is not transmitted, or is transmitted at least only partially, to the anchor structures. With the removal of the tensile force, the thread relaxes, that is, it shortens, again as a result of the elastic restorative force, whereby the anchoring structures anchor themselves in the tissue and can, for example, approximate the edges of the wound or stretch the skin in cosmetic surgery.

[0011] Preferably, the anchor structures in an erected state form an angle of between 10 and 80 °, more particularly between 15 and 70 ° and preferably between 20 and 60 °, with the surface of the wire. In another embodiment, the anchoring structures in the absence of an axial tensile load on the thread, that is, in the relaxed state of the thread, are formed on the surface of the wire at a density of between 1 and 30 and more particularly between 4 and 20 per cm of thread length (projected at intervals on the longitudinal axis of the thread).

[0012] The thread of the present invention generally comprises a main body of the thread, on whose surface the anchoring structures for anchoring in biological tissues, more particularly human and / or animals, are formed. The main body of the thread usually has an elongated shape. Preferably, the main body of the thread and the anchor structures are formed in one piece. In principle, the main body of the thread and the anchoring structures can be formed by different elastomeric materials, more particularly elastomers. Preferably, the anchoring structures are formed by the same elastomeric material, more particularly by the same elastomer, as the main body of the thread. In a possible embodiment, the main body of the thread is formed by an elastomeric material, more particularly an elastomer, and the anchor structures are formed by a non-elastomeric material, more particularly non-elastomeric polymer. With respect to possible elastomeric materials, more particularly elastomers, reference is made to the following description in its entirety.

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[0013] The yarn of the present invention may be made in principle of any suitable elastomeric material. Preferably, the yarn material comprises a polymer with elastomeric properties, that is, an elastomer. The polymer can be a homo-, co-, ter- or tetrapolymer and the like. In the following, the term "copolymers" should be understood as meaning generally polymers composed of two or more different monomer units. In other words, the copolymers useful for the purposes of the present invention may also comprise terpolymers, tetrapolymers and the like. Suitable elastomers are more particularly formed as block polymers or segmented polymers. Formation as co-, ter- or tetrapolymers and other random or accidental or alternate is similarly possible according to the present invention. It is particularly preferable according to the present invention when the yarn is formed by a block copolymer, block terpolymer, segmented polymer or a polymer mixture. The block copolymer or block terpolymer may more particularly comprise a multi-block copolymer and a multi-block terpolymer, respectively. More particularly, the yarn may be formed by a thermoplastic elastomer. Thermoplastic elastomers generally comprise plastics that at room temperature behave comparablely to classical elastomers, but which, when heated, are plastically deformable and thus show thermoplastic behavior. Ideally, thermoplastic elastomers useful according to the present invention have a transition temperature to the plastic deformed behavior that is sufficiently above a patient's body temperature. The use of thermoplastic elastomers has the advantage that they are significantly better for the process than classical elastomers. Classic elastomers are generally chemically crosslinked spatial network molecules in the form of a broad mesh where the crosslinks cannot generally be broken without decomposition of the elastomeric material. Instead, thermoplastic elastomers include subregions of physical cross-linking points that can be broken with heating without decomposing the thermoplastic elastomeric material as a result.

[0014] In an advanced embodiment, the elastomeric yarn is formed by non-absorbable, partially absorbable or fully absorbable elastomers. The non-absorbable elastomers are preferably selected from the group consisting of olefin-based thermoplastic elastomers, urethane-based thermoplastic elastomers, or thermoplastic polyurethanes, thermoplastic copolyesters, styrene block copolymers, thermoplastic copolyamides, silicone elastomers, copolymers thereof and mixtures thereof. For example, the yarn may be formed by a non-absorbable elastomer of the group consisting of acrylic rubber, polyester-urethane rubber, brominated butyl rubber, chlorinated butyl rubber, chlorinated polyethylene, epichlorohydrin homopolymer, polychloroprene, sulfonated polyethylene, ethylene rubber -acrylate, epichlorohydrin copolymer, sulfur-crosslinked ethylene-propylene-diene rubber, peroxide cross-linked ethylene-propylene copolymer, polyether-urethane rubber, ethylene-vinyl acetate copolymer, fluorinated rubber, fluorosilicone rubber, rubber hydrogenated nitrile, butyl rubber, dimethylpolysiloxane containing vinyl, nitrile rubber, butadiene-acrylonitrile rubber, natural rubber, thioplasts, polyfluorophosphazenes, polynorbornene, styrene-butadiene rubber, nitrile carboxyl rubber, copolymers thereof and mixtures thereof the same. The thermoplastic polyurethanes mentioned in this section may in principle comprise aliphatic or aromatic polyurethanes. Polyurethanes can be more particularly branched or unbranched. According to the present invention, unbranched aliphatic thermoplastic polyurethanes are preferred. In an advanced embodiment, the thermoplastic polyurethanes are selected from the group consisting of aliphatic polycarbonate urethanes, aromatic polycarbonate urethanes, silicone polycarbonate urethanes, polyether silicone urethanes and combinations thereof. Polycarbonate urethanes are generally prepared starting from a polycarbonate having terminal hydroxyl groups, an aromatic diisocyanate and also an oligoglycol or polyglycol.

[0015] In another embodiment, the elastomeric yarn is composed of absorbable elastomers selected from the group consisting of polyhydroxybutyrates, block copolymers thereof, block terpolymers thereof and combinations, more particularly mixtures thereof. Suitable block copolymers comprise glycolide, lactide, £ -caprolactone, trimethylene carbonate, p-dioxanone, 3-hydroxybutyrate and / or 4-hydroxybutyrate. Advantageous block terpolymers comprise glycolide, lactide, £ -caprolactone, trimethylene carbonate, p-dioxanone, 3-hydroxybutyrate and / or 4-hydroxybutyrate. For example, the yarn of the present invention may be formed by a triblock terpolymer comprising glycolide, trimethylene carbonate and--caprolactone. Such tribloque terpolymer is commercially available, for example, under the name of Monosyn®. The aforementioned polyhydroxybutyrates preferably comprise poly-3-hydroxybutyrate and / or poly-4-hydroxybutyrate.

[0016] In a further embodiment, the anchor structures and the surface of the thread are formed in one piece. The anchor structures are preferably formed of the elastomeric yarn material. The anchor structures are preferably formed as cuts on the surface of the elastomeric thread. The cuts may comprise mechanical, physicochemical, more particularly laser, or thermal cuts. The cuts may have a depth of cut, measured perpendicularly from the surface of the thread, between 5 and 60%, more particularly between 15 and 50%, preferably between 20 and 40%, based on the diameter of the thread .

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[0017] In another embodiment, the anchoring structures by imposing an axial tensile load on the thread form a barb, blazon, shield, scale, wedge, skewer, arrow, V shape and / or W shape. Particularly preferable according to the present invention is that the anchor structures are designed as barbed or as barbed.

[0018] The anchoring structures can, by imposing an axial tensile load on the thread, in principle be formed in different arrangements on the surface of the thread. For example, the anchor structures may in this case have a row-shaped arrangement, a stepped arrangement, a zigzag-shaped arrangement, a spiral-shaped arrangement, a helical-shaped arrangement, a random arrangement or combinations of the same in the longitudinal and / or transverse direction, preferably in the longitudinal direction, of the thread.

[0019] In another embodiment, the elastomeric yarn when imposing an axial tensile load includes at least one set, more particularly two, three or more sets, of anchoring structures. A set of anchor structures should be understood here as meaning an arrangement of anchor structures in the thread that matches the configuration of the anchor structures, for example, the length of the anchor structures, the height of the anchor structures, the depth of cut of the anchor structures, the angle of the anchor structures that form the anchor structures in the erect state with the surface of the thread, the orientation of the anchor structures and / or the figure or Anchor structures shape.

[0020] In a possible embodiment, the anchoring structures when an axial tensile load is imposed on the thread form a unidirectional arrangement on the surface of the thread. In other words, the anchor structures in this embodiment point uniformly in one direction.

[0021] In a particularly preferred embodiment, the elastomeric thread upon imposing an axial tensile load has a so-called bidirectional arrangement of the anchoring structures on the surface of the thread. A bidirectional arrangement of the anchor structures should be understood herein as meaning an arrangement where the anchor structures are formed in two different directions (bidirectionally) on the surface of the thread. Preferably, seen in the longitudinal direction of the thread, the anchoring structures point in a first portion of the thread in the direction of a remaining second portion of the thread and in the remaining second portion of the thread point in the direction of the first portion of the thread. For example, seen in the longitudinal direction of the thread, the anchoring structures in a first portion of the thread can be formed in the direction of the center of the thread and in a remaining second portion of the thread can also be formed in the direction of the center of the thread. Here the length of the thread parts may correspond approximately to half the length of the thread.

[0022] In an advanced embodiment, the elastomeric yarn when an axial tensile load is imposed shows at least two bi-directional arrangements of anchoring structures on its surface. It is particularly preferable when, with respect to a first bidirectional arrangement of the anchor structures, a second bidirectional arrangement of the anchor structures is formed on the surface of the thread in the circumferential direction of the thread of approximately 180 ° and preferably compensated with the first bidirectional layout It can be further provided according to the present invention that the elastomeric yarn shows the three bidirectional arrangements of the anchoring structures when imposing an axial tensile load. It is preferable in this case when, with respect to a first bidirectional arrangement of the anchor structures, a second bidirectional arrangement of the anchor structures is formed on the surface of the thread in the circumferential direction of the thread of approximately 120 ° and preferably compensated with the first bidirectional arrangement, and this second bidirectional arrangement of the anchor structures is in turn formed in the circumferential direction of the wire of approximately 120 ° and preferably compensated with respect to a third bidirectional arrangement of the anchor structures, so that the Third bidirectional arrangement of the anchor structures is formed similarly in the circumferential direction of the wire of approximately 120 ° and preferably compensated with respect to the first bidirectional arrangement of the anchor structures.

[0023] In a further preferred embodiment, the anchoring structures when an axial tensile load is imposed on the thread have a periodically changing orientation, more particularly, alternating, on the surface of the thread. For example, seen in the longitudinal direction of the thread, the anchoring structures in a first portion of the thread can be formed in the direction of a second portion of the thread and in the second portion of the thread in the direction of the first portion of the thread, in a third portion of the thread adjacent to the second portion of the thread in the direction of a fourth portion of the thread and in the fourth portion of the thread in the direction of the third portion of the thread, and so on.

[0024] It can also be provided according to the present invention that the elastomeric yarn shows regions of areas or parts of areas without anchoring structures. Preferably, the thread shows an area portion without anchoring structures approximately in the region of the center of the thread. This portion of area, seen in the longitudinal direction of the

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thread, can have a length of between 0.5 and 5 cm, more particularly between 1.5 and 3 cm. This makes it possible to place the ends of the thread side by side to form a loop and to attach them to a surgical insertion instrument, preferably to a surgical needle. In this embodiment, the remaining parts of the thread area preferably show a bidirectional arrangement of the anchor structures, so that, after the formation of the loop, the anchor structures point unidirectionally in the direction of the loop. Since the center of the thread is generally used for the closure of the actual wound, a thread whose center of the thread is essentially free of anchoring structures can be used with particular advantage to avoid further irritation of the tissue in the region of the wound. With respect to the arrangement possibilities for the anchoring structures on the surface of the thread when an axial tensile load is imposed on the thread, reference is made to the description so far.

[0025] In a further embodiment, the anchor structures include a coating, preferably a hardening coating. The coating is preferably only formed in the region of the anchor structures, more particularly exclusively in the anchor structures. According to the present invention, the coating can only be partially formed in the anchor structures. For example, the coating can only be formed on the underside of the anchor structures. In addition, the coating can only be formed in the region of the ends that protrudes from the surface of the thread, preferably only at the tips, of the anchoring structures, more particularly on both sides thereof. However, it is preferable that the coating completely surrounds the anchor structures, that is, that the surface of the anchor structures is completely covered with the coating. The coating preferably comprises a proportion between 0.5% and 25% by weight, more particularly between 1% and 20% by weight and preferably between 2% and 15% by weight, based on the total weight of the yarn. In general, the thickness of the coating layer is chosen so that the coated anchor structures continue to protrude from the surface of the wire. The thickness of the coating layer is preferably between 1 and 100 pm, more particularly between 2 and 50 pm and more preferably between 4 and 40 pm. In general, the coating is made of a different material than the thread per se. Preferably, the coating includes a biocompatible material, more particularly polymer, with a flexural modulus> 1500 N / mm2, preferably> 4000 N / mm2. More particularly, the coating is formed by such material, more particularly polymer.

[0026] The coating, which is preferably a hardening coating, can also be formed to be fully absorbable, partially absorbable or non-absorbable. More particularly, the hardening coating may include an absorbable polymer and more particularly be formed by such a polymer. Useful polymers include in particular polyhydroxyalkanoates, copolymers thereof and combinations thereof. The coating preferably includes an absorbable polymer selected from the group consisting of polylactide, polyglycolate, polycaprolactone, polytrimethylene carbonate, poly-p-dioxanone, copolymers thereof and combinations, more particularly mixtures thereof. Preferably the coating is formed by one of the polymers mentioned in this section, copolymers mentioned in this section or by one of the combinations mentioned in this section, more particularly mixtures thereof.

[0027] In an alternative embodiment, the coating, preferably hardening coating, includes a non-absorbable polymer, more particularly selected from the group consisting of polyethylene terephthalate, polypropylene, polyvinylidene difluoride, polytetrafluoroethylene, polyhexafluoropropylene, polyamides, copolymers of the same and combinations, more particularly mixtures, thereof. Preferably, the coating is formed by a polymer or copolymer mentioned in this section or by one of the combinations, more particularly mixtures, mentioned in this section.

[0028] In another embodiment, the yarn has a linear tensile strength of between 30 and 500 N / mm2, more particularly between 50 and 350 N / mm2, based on a thread without anchoring structures. The yarn of the present invention can also have a breaking elongation of between 50 and 700%, more particularly between 80 and 600%, preferably between 150 and 500%. The wire preferably has a flexural modulus of 3 to 300 N / mm2, more particularly 5 to 200 N / mm2.

[0029] In principle, the yarn of the present invention can be formed as a monofilament or as a multifilament, more particularly as a braided or interwoven multifilament. Preferably, the elastomeric yarn is formed as a monofilament or as a monophilic yarn. It is also possible according to the present invention that the thread is formed as a pseudomonofilament.

[0030] In a further embodiment, the yarn is designed as a solid or solid yarn. As used herein, the term "solid or solid yarn" may in particular mean that the yarn has no lumen.

[0031] In an alternative embodiment, the thread is designed as a hollow thread, in particular as a tubular thread, preferably as a flexible tube or tube. The hollow thread can be represented in particular by a wall

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closed covering a lumen, where the ends of the hollow thread are preferably open. The hollow thread can be produced by extrusion. In addition, the hollow thread may have an internal diameter <1 cm, in particular <5 mm, preferably <2 mm. The anchoring structures, by imposing an axial tensile load on the hollow wire, can be arranged inside and / or outside, preferably outside, of the hollow wire. The anchor structures can be cut in the wall of the hollow thread, where the cuts do not cross the wall of the hollow thread, and / or they can be present as through cuts, that is to say the anchor structures completely cross the wall of the hollow thread.

[0032] The hollow threads according to the present invention can be used in various fields of medicine. For example, hollow threads can be used as self-anchoring infusion tubes, delivery tubes, catheters, distribution systems for medications, in particular liquid medications, drug release systems or drainage systems, in particular drain pipes. In addition, the hollow threads can be applied, in particular shrunk and / or extracted, in a round bar, fiber, monofilament, pseudomonofilament, multifilament, skein, thread or the like to equip these structures with self-anchoring properties.

[0033] The wire according to the present invention generally has a circular cross section. However, other forms of cross-section are also conceivable. For example, the thread may have an oval, triangular, trilobular, square, trapezoidal, rhomboid, pentagonal / five-corner, hexagonal / six-corner, star-shaped or cruciform cross-section. Such cross-sectional shapes are easily achievable with the help of appropriate extrusion dies that can be customized for any desired cross-sectional shape.

[0034] In a further embodiment, the elastomeric yarn includes added substances, more particularly biological and / or medical assets. For example, the thread may include antimicrobial assets, disinfectants, growth promoters, anti-inflammatories, blood coagulants, soothing (analgesics) and / or odor controllers.

[0035] In another embodiment, the elastomeric yarn is present in the form of a continuous filament yarn, in particular continuous filament fiber, or as a converted fiber, more particularly, cut to size.

[0036] In another embodiment, the elastomeric yarn is fitted at least at one end, preferably at both ends, with a surgical insertion instrument. The surgical insertion instrument preferably comprises a surgical needle. The use of a cannula as an insertion instrument is similarly possible according to the present invention. Preferably, at least one end of the cannula has been sharpened with an oblique grinding so that a small cut can be made in tissue penetration. Alternatively, the cannula may also have a frustoconical and more particularly pointed end. In the case of the loop-shaped wire described above, it is generally the case in which both ends of the wire are fixed to a surgical insertion instrument. However, when the wire has a bidirectional arrangement of the anchor structures, it is preferable according to the present invention when the two ends of the wire are each connected to a surgical insertion instrument. To connect the thread to a surgical insertion instrument, the thread can be inserted into a dedicated perforated hole in the insertion instrument and the insertion instrument can subsequently be compressed or closed in the region of the perforated hole.

[0037] To prevent bleeding from the puncture channel, it can be further provided according to the present invention that the thread has a smaller diameter in the region of its ends than in the remaining regions of the thread. In other words, the ends of the thread may have a frustoconical diameter. Such a thread is particularly advantageously combined with a surgical insertion instrument, for example, a surgical needle, which is actually designed for a smaller thread diameter. In this way, the diameter of the thread can be conformed to the diameter of the insertion instrument. According to the present invention, a proportion of diameter of surgical insertion instrument for thread less than 2: 1, preferably 1: 1, can be especially provided. As a result, a puncture channel formed by the surgical insertion instrument can be better filled by regions of the thread having the original diameter, that is, without truncating. A puncture channel whose diameter is very close to the diameter of the thread is advantageous to ensure a better anchoring of the thread in the fabric. To truncate the diameter, the thread can be trimmed in the region of its ends. Thermal methods or laser techniques can be used for this example. The transition from the original wire diameter to the frustoconical diameter in the region of the wire ends may be abrupt or continuous, more particularly in the form of a gradient. To form a gradual transition, extrusion technology is particularly convenient. The take-off speed involved in the extrusion of a thread can be varied, more particularly periodically. This can be achieved, for example, by modulating the circumferential speed of the cylinder responsible for thread takeoff. Alternatively, additional cylinders can be interposed between the extruder nozzle and the take-off cylinder.

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[0038] In a particular embodiment, the thread is fixed in its elongated state or stretched in the lumen of a blunt end of a cannula. This results in a small proportion of the outer diameter of the cannula and diameter of the thread. Preferably, the cannula is longer than the recovery distance through the tissue. This can be done, for example, by temporarily fixing the elastomeric thread in the stretched state (with frustoconical diameter) by freezing and then pushing it into the cannula. As it defrosts, then the thread is anchored in the cannula as it shortens and its diameter increases, resulting in an optimal proportion of needle / thread diameter.

[0039] In another embodiment, the elastomeric yarn is present in a removed or unstretched state.

[0040] A further aspect of the present invention relates to a wound closure system or surgical fixation means, more particularly a wound closure system without knots or self-fixation or surgical fixation means, preferably in the manner of a surgical suture, more particularly knotless or self-locking surgical suture, which includes an elastomeric yarn according to the present invention. The wound closure system is generally present as a wound closure system in the form of a thread. As such, the wound closure system is preferably formed to be monofilament. In principle, however, the wound closure system can also be formed to be multifilament. With regard to the features and additional details about the wound closure system, reference is made to the description so far.

[0041] The present invention further provides a surgical equipment of parts that includes an elastomeric thread or a wound closure system according to the present invention and at least one surgical insertion instrument. As mentioned, the surgical insertion instrument may comprise a surgical needle or a cannula. With regard to the additional features and details about the equipment of parts, reference is also made to the description so far.

[0042] The present invention further relates to a process for producing a thread of the present invention, where anchoring structures are formed on the surface of an elastomeric thread.

[0043] In a preferred embodiment, the anchor structures are formed by cutting on the surface of the thread.

[0044] In an advanced embodiment, the anchor structures are mechanically cut into the thread, preferably by means of at least one cutting blade, for example, a microtome knife or, alternatively, by a needle, in particular a surgical needle, to less affect the mechanical stability of the thread. Common cutting devices can be used for this purpose. Useful cutting devices generally comprise a cutting board, at least one cutting blade and also retaining or fixing elements for the thread, for example, a vice, clamps or retention or clamping jaws. For example, the cutting of the anchoring elements can mechanically use a cutting board (cutting support) with a groove, where the groove is intended to receive the thread to be cut. Depending on the depth of the groove, the use of at least one cutting blade allows specific control of the cutting depth at which the anchor structures are cut in the thread. This is because at least one cutting blade is generally configured so that with this only at most the regions of the thread protruding from the groove can be cut. This contributes with particular advantage to the improvement of the consistency of cutting in the process of the present invention.

[0045] In an alternative embodiment, the anchor structures are thermally cut in the wire, preferably in a temperature range of between 10 and 100 ° C, more particularly between 20 and 50 ° C, above the melting point of the thread material. The thermal cutting of the anchoring structures has the great advantage over the mechanical cutting of the fact that the cuts in the wire that are produced by thermal cutting are less frustoconical, more particularly less acute, than the results of the purely mechanical cutting. This can be used to minimize the risk of the thread developing, under load, a tear that begins at the ends of the respective cuts. In an advanced embodiment, the anchor structures are cut in the wire by means of a cutting wire, more particularly metal wire, suitable for this purpose. A heated cutting wire, more particularly electrically heated, can be used, for example. The cutting wire preferably comprises a fine wire. Preference is given to the use of a cutting wire with a diameter of between 20 and 50 pm. As an alternative to a single cutting wire, it is also possible to use a sheet of cutting wires. Similarly, it is possible according to the present invention to use a metal grid.

[0046] In another alternative embodiment, the anchor structures are cut in the wire by laser cutting techniques. Useful lasers include in principle not only gas lasers, for example CO2 lasers, but also solid state lasers, for example Nd: YAG lasers. In general, a suitable laser cutting machine consists of a laser beam source, a beam guide and a mobile system of focusing optics (concave mirror or positive lens). The beam that comes out of the beam source is guided well through a fiber

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optics in the case of an Nd: YAG laser, for example, or via a deflecting mirror in the case of a CO2 laser, for example, to the mechanical optics that focus the laser beam and thus produce the power densities required for the cut, which generally range from 106 to 109 W / cm2. Appropriate laser cutting processes are well known to one skilled in the art, so that far-reaching observations can be dispensed here.

[0047] In a particularly preferred embodiment, the anchor structures are coated with a material, preferably a hardening material, more particularly a hardening polymer. Preferably, the thread is extended / stretched by applying an axial tensile force, preferably at the ends of the thread, to coat the anchor structures. Here the anchoring structures, which are generally not subject to any significant extension or stretching, are preferably completely coated with the material and thus harden. According to the present invention, the anchor structures can be coated by immersion in a coating solution or by deposition of a material from the gas phase. As a result, the relatively long anchor structures, which in contrast to the relatively short anchor structures generally have a higher flexural relaxation, can be hardened in particular, whereby their overall anchoring performance is improved. It is particularly preferable when the thread is stretched (stretched) and relaxed alternately until the hardening material has cured. This measure makes it possible to prevent the elastic properties of the main body of the thread (thread body without the spikes) from being damaged or totally lost.

[0048] The cutting of the anchoring structures can be carried out in the state extracted or not extracted from the thread. Any extraction is preferably performed while heat is applied. To produce an advantageous heat for the extraction operation, hot water or infrared radiation can be used, for example. Similarly it is possible according to the present invention that the extraction is carried out in a heating oven suitable for this purpose. To extract the thread, it is normally guided on a roller or cylinder system comprising a set of rollers or cylinders that can have different rotation speeds. Generally, each rear roller has a higher rotation speed than the preceding roller of the extraction system. However, alternatively to the continuous extraction just described, it is also possible according to the present invention to carry out discontinuous extraction. For discontinuous extraction, the thread can be held between the clamping jaws of a clamping device and subsequently extracted.

[0049] After the extraction, optionally also independently of any extraction, of the thread, it can be provided according to the present invention that the thread be subjected to several post-treatment steps. In general, for this the thread is conditioned with vacuum heat or under reduced pressure. This can be used to increase the crystallinity of the yarn and, more particularly, to lower the residual monomer content. An additional advantage that can be achieved through thread post-treatment refers to the reduced susceptibility to shrinkage.

[0050] To minimize the angle of straightening of the anchor structures, the thread can be subjected to a relaxation, in particular contraction, after an extraction. This is particularly advantageous with respect to polymers with a high extraction rate. Such polymers can otherwise contribute to anchoring structures that can protrude perpendicularly from the surface of the wire by imposing an axial tensile load on the wire. In addition, due to a relaxation, the elasticity of the yarn can be improved, which is advantageous in view of the manipulation of properties and a more equal transfer of force in a tissue to be treated.

[0051] In a further embodiment, the thread can be subjected to a relaxation, in particular contraction. Subsequently, the anchor structures are cut into the relaxed thread. Then, the cut thread is removed. Thus, the straightening angle of the anchor structures can also be minimized.

[0052] The present invention further provides the use of the thread of the present invention to produce a wound closure system or surgical fixation means, more particularly a wound closure system without knots or self-fixation or fixation means, preferably in the mode of a surgical suture, more particularly in the mode of a surgical suture without knots or self-fixation. The wound closure system or surgical fixation means is preferably useful for tissue fixation or tissue elevation. With regard to additional features and details, reference is made to the description so far in its entirety.

[0053] A further aspect of the present invention encompasses the use of the thread of the present invention in the production of a fixation means for implants, more particularly textile implants. With regard to additional features and details, reference is made similarly to the description so far in its entirety.

[0054] Finally, the present description also refers to an exemplary process to approximate, fix and / or gather biological tissue, more particularly human and / or animal, which includes the steps of:

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a) insert an elastomeric thread into the fabric that shows anchoring structures on its surface to

anchoring in biological tissues, more particularly human and / or animals,

b) apply an axial tensile force to the inserted wire, more particularly at its ends, and

c) reduce, more particularly eliminate, the axial tensile force.

[0055] The elastomeric yarn according to the present invention is particularly useful as a wound closure system without knots or self-fixation or surgical fixation means showing anchor structures formed in an elastomeric yarn material. When the thread is in a relaxed state, that is, without spreading, the anchoring structures combine with the remaining regions of the thread to form a smooth surface for the thread.

[0056] When the thread is then pulled through a biological tissue, generally human or animal, this is preferably done by applying a force less than the force needed to erect the anchoring structures. This is particularly advantageous to completely avoid tissue trauma. If desired, however, it can also be provided according to the present invention that the thread is inserted into a biological tissue using a force that leads to an erection or minimal deployment of the anchoring structures. The tissue trauma caused by this then remains significantly less than when the thread is introduced into a biological tissue with the anchor structures erected or deployed to the maximum. Once the thread is optimally placed according to the surgeon, the anchor structures are erected by exerting a tensile force on both ends of the thread. After removal of the tensile force from the ends of the thread, the thread is shortened, and the anchoring structures anchor themselves and, therefore, the thread in the fabric. Since, however, the thread does not shorten to its original length and, therefore, remains under a certain tension, the tissue, more particularly, the edges of the wound, approximates, fixes and / or gathers . Since anchoring structures are only erected by imposing a certain tensile load on the thread in its longitudinal direction (axial tensile load), no additional help is needed to introduce the thread into a biological tissue. This makes the manipulation of the thread of the present invention simple and free of complications. It is an additional advantage of the yarn of the present invention that in practice can be used as a surgical suture without knots or self-fixation. Since surgeons are familiar enough with such sutures, this results in an additional advantage for the practical handling of the thread of the present invention.

[0057] Additional features of the invention become apparent from the following description of preferred embodiments by reference to examples and a figure description in conjunction with the features of the secondary claims and the figure. The individual features here can be updated alone or two or more at once in combination with each other, according to the appended claims.

1. Description of the figure

[0058] The unique figure represents a preferred embodiment of a thread of the invention 100. The thread 100 has a main body of the thread 110 with anchoring structures 120 formed on its surface. In the relaxed state (without spreading or stretching), the anchoring structures 120 combine with the main body of the wire 110 to form a smooth surface for the wire (fig. 1A). In this state, the thread can be pulled with particular advantage through a biological tissue without significant trauma to the tissue as a result. Advantageously, the thread can also be moved in a biological tissue in a direction opposite to the potential blocking direction. When the thread 100 is subjected to the imposition on it of a certain tensile force in the longitudinal direction of the thread 100, preferably at the ends of the thread, the anchoring structures 120 are erected (Figures 1B and 1C). The application of the tensile force reduces the diameter of the main body of the thread. However, the tensile force is transmitted only partially, at most, to the anchor structures 120. When the thread 100, therefore, is used as a surgical suture, the anchor structures 120 -after placement correct thread 100 in a biological tissue - can be erected by applying an axial tensile force to establish contact with the surrounding region of the tissue. The elimination of the axial tensile force causes the anchoring structures to be anchored in the biological tissue, since the anchoring structures are pulled laterally, by means of the longitudinal contraction of the thread (due to the elimination of the tensile force axial), of the thread 100 in the fabric. Elastic traction prevents anchoring structures from becoming free again. As a result, the tissue can be approximated, fixed and / or assembled as desired. In other words, an approximation, fixation and / or active gathering of the tissue rests on the elastic restorative force of the thread 100.

2. Examples

2.1 Production of monofilaments from a thermoplastic elastomer (Vasomer)

[0059] The Vasomer is a linear aliphatic polyurethane and a thermoplastic elastomer that is approved for medical implants and has a Shore A hardness of 76. The Vasomer was processed in monofilaments in a TW 100 extruder.

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(twin screw extruder with Haake Rheocord 90 transmission). The cooled feed zone was followed by an increasing temperature profile in the extruder zones of 160 ° C in the zone 1 to 200 ° C at the turning head. The turning head was equipped with a 1.25 mm die with UD 8. The mass production was adjusted merely via the speed of the spindles. To solidify the extruded chain after a 7 cm air duct, it was extracted through a cold water bath at 20 ° C and subsequently rolled into a drum. In total, monofilaments were produced in two sizes. These are reproduced below in table 1.

Table 1

 Monofilament

 MV1 MV2

 Spindle speed [r.p.m.]

 24 22

 Die Pressure [bar]

 45 40

 Winding speed [m / min]

 13.0 6.4

 Diameter [mm]

 0.80 1.05

[0060] The monofilament flexural modulus, as measured in a Franck 58963 flexural stiffness tester at a fixed length of 5 mm and a 30 ° bend angle, was merely 6 N / mm2.

[0061] The strain strain measurements and also the hysteresis tests on reversible elasticity were performed on a Zwick 1455 strain tester. The maximum force for MV2 was found to be 39.1 N. The corresponding extent was 410% ± 10%. . Since the original diameter was approximately divided in two in elongation around 400%, forces close to the requirements of the USP for surgical sutures were obtained. Hysteresis tests at 200% and 300% showed almost complete reversibility.

2.2 Production of a Vasomer monofilament with spikes

[0062] The MV2 cut of Example 2.1 was made in a specially designed prototype cutting machine. The cutting device used was a microtome knife, which cut the MV2 monofilament pneumatically and at controllable time intervals. The cutting stop and conveyor used was a cutting wheel that was equipped with a fine guide groove and on which the Vasomer monofilament was fixed or adhered with the greatest minimum elongation. The cutting wheel itself was driven at a controllable speed. The cutting length, cutting angle and resulting cutting depth (perpendicular to the monofilament surface) could also be varied. The results reproduced below are obtained in Table 2.

Claims (15)

5 10 fifteen twenty 25 30 35 40 Four. Five fifty 55 60 1. Elastomeric thread (100), more particularly for use as a wound closure system without knots or self-fixing, where the thread (100) includes on its surface anchoring structures (120) for anchoring in biological tissues, more particularly human and / or animals, characterized in that the anchoring structures (120) in the absence of an axial tensile load in the thread (100) essentially do not protrude from the surface of the thread, so that the thread (100) has an essentially smooth surface and anchoring structures (120) are configured to be erected by imposing an axial tensile load on the thread (100). 2. Elastomeric thread (100) according to claim 1, characterized in that the anchoring structures (120) are configured to be erected reversibly by imposing an axial tensile load on the thread (100). 3. Elastomeric thread (100) according to claim 1 or 2, characterized in that the thread (100) is formed by a block copolymer, block terpolymer, segmented polymer or polymer mixture. 4. Elastomeric thread (100) according to any of the preceding claims, characterized in that the thread (100) is formed by a thermoplastic elastomer. 5. Elastomeric thread (100) according to any of the preceding claims, characterized in that the thread (100) is formed by non-absorbable elastomers selected from the group consisting of olefin-based thermoplastic elastomers, urethane-based thermoplastic elastomers, or thermoplastic polyurethanes, thermoplastic copolyesters, styrene block copolymers, thermoplastic copolyamides, silicone elastomers and mixtures thereof. 6. Elastomeric yarn (100) according to any one of claims 1 to 4, characterized in that the yarn (100) is formed by absorbable elastomers selected from the group consisting of polyhydroxybutyrates, block copolymers comprising glycolide, lactide, £ -caprolactone, trimethylene carbonate, p-dioxanone, 3- hydroxybutyrate and / or 4-hydroxybutyrate, and block terpolymers comprising glycolide, lactide, £ -caprolactone, trimethylene carbonate, p-dioxanone, 3-hydroxybutyrate and / or 4 -hydroxybutyrate. 7. Elastomeric thread (100) according to any of the preceding claims, characterized in that the anchoring structures (120) are formed as cuts in the surface of the thread (100). 8. Elastomeric thread (100) according to any of the preceding claims, characterized in that the anchoring structures (120) by imposing an axial tensile load on the thread (100) form a unidirectional or bidirectional arrangement on the surface of the thread (100). 9. Elastomeric thread (100) according to any one of claims 1 to 7, characterized in that the anchoring structures (120) when imposing an axial tensile load on the thread (100) point at a first portion of the thread in the direction of a remaining second portion of the thread and in the remaining second portion of the thread point in the direction of the first portion of the thread. 10. Elastomeric thread (100) according to any of claims 1 to 7, characterized in that the anchoring structures (120) when imposing an axial tensile load on the thread (100) have a periodically changing orientation, more particularly alternating, on the surface of the thread. 11. Thread (100) according to any of the preceding claims, characterized in that the anchoring structures (120) are coated with a hardening material, more particularly with a hardening polymer. 12. Elastomeric thread (100) according to any of the preceding claims, characterized in that the thread is designed as a solid thread or as a hollow thread, in particular as a tubular thread, preferably as a tube. 13. Wound closure system, preferably in the manner of a surgical suture, which includes an elastomeric thread (100) according to any of the preceding claims. 14. Part surgical equipment, which includes an elastomeric thread (100) according to any one of claims 1 to 12 or a wound closure system according to claim 13 and at least one surgical insertion instrument. 15. Process for producing an elastomeric thread (100) with anchor structures (120) on its surface according to any of claims 1 to 12, characterized in that the anchor structures (120) are formed on the surface of a elastomeric thread. image 1